A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
Phase 2
Completed
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT00377182
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
Inclusion Criteria
- adult patients, 18-65 years of age;
- CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
- chronic liver disease consistent with CHC.
Exclusion Criteria
- infection with any HCV genotype other than genotype 1;
- previous treatment for CHC;
- medical condition associated with chronic liver disease other than CHC;
- HIV, Hepatitis A, Hepatitis B infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RO5024048 1500mg in combination with PEGASYS PEGASYS - RO5024048 in combination with PEGASYS and COPEGUS PEGASYS - PEGASYS with COPEGUS PEGASYS - RO5024048 1500mg in combination with PEGASYS RO5024048 1500mg - PEGASYS with COPEGUS Copegus - RO5024048 3000mg in combination with PEGASYS RO5024048 3000mg - RO5024048 3000mg in combination with PEGASYS PEGASYS - RO5024048 in combination with PEGASYS and COPEGUS Copegus - RO5024048 in combination with PEGASYS and COPEGUS RO5024048 1500mg -
- Primary Outcome Measures
Name Time Method Adverse events (AEs) and laboratory parameters. Week 4, 8 and Week 72
- Secondary Outcome Measures
Name Time Method Plasma concentration of HCV polymerase inhibitor Week 4 and 8 Antiviral activity Week 4, 8 and Week 72